News & Events

• June 1, 2018
  

  Selection of and evidentiary considerations for wearable devices and their measurements for use in regulatory decision making:  recommendations from the ePRO Consortium

  Byrom B, Watson C, Doll H, Coons SJ, Eremenco S, Ballinger R, McCarthy M, Crescioni M, O’Donohoe P, Howry C. Selection of and evidentiary considerations for wearable devices and their measurements for use in regulatory decision making:  recommendations from the ePRO Consortium.  Value in Health 2018;21:631-639.

• March 14, 2018
  

  Towards Bridging Translational Gap in Cardiotoxicity Prediction: an Application of Progressive Cardiac Risk Assessment Strategy in TdP Risk Assessment of Moxifloxacin

  Patel N, Hatley O, Berg A, Romero K, Wisniowska B, Hanna D, et al. Towards Bridging Translational Gap in Cardiotoxicity Prediction: an Application of Progressive Cardiac Risk Assessment Strategy in TdP Risk Assessment of Moxifloxacin. AAPS J. 2018 May 1;20(3):47.

• March 8, 2018
  

  Quantitative Approach for Cardiac Risk Assessment and Interpretation in Tuberculosis Drug Development

  Polak S, Romero K, Berg A, Patel N, Jamei M, Hermann D, et al. Quantitative approach for cardiac risk assessment and interpretation in tuberculosis drug development. J Pharmacokinet Pharmacodyn. 2018 Mar 8;1–11.

• February 27, 2018
  

  Patient-Reported Outcome (PRO) Consortium Translation Process: Consensus Development of Updated Best Practices

  Eremenco S, Pease S, Mann S, Berry P, on behalf of the PRO Consortium’s Process Subcommittee. Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices. Journal of Patient-Reported Outcomes. 2017;(2):12.

• January 22, 2018
  

  Candidate biomarkers for the diagnosis and prognosis of drug-induced liver injury: An international collaborative effort

  Church RJ, Kullak-Ublick GA, Aubrecht J, Bonkovsky HL, Chalasani N, Fontana RJ, et al. Candidate biomarkers for the diagnosis and prognosis of drug-induced liver injury: An international collaborative effort. Hepatology. 2018 Jan 22.